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Sangamo Therapeutics, Inc. (SGMO)

Q1 2010 Earnings Call· Mon, May 3, 2010

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Transcript

Operator

Operator

Good day, ladies and gentlemen, and welcome to Sangamo BioSciences first quarter conference call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will be given at that time. (Operator Instructions) As a reminder, this conference call is being recorded. I would now like to hand the conference over to your host, Ms. Elizabeth Wolffe, Director of Corporate Communications. Ma'am, you may begin.

Elizabeth Wolffe

Management

Thank you very much. Good afternoon and thank you for joining Sangamo's management team on our conference call to discuss the company's first quarter 2010 financial results. Also present during this call are several members of Sangamo's senior management including Edward Lanphier, President and Chief Executive Officer, Ward Wolff, Executive Vice President and Chief Financial Officer and Dale Ando, Vice President of Therapeutic Development and Chief Medical Officer. Following this introduction, Edward will highlight recent activities, Ward will then briefly review first quarter financial results for 2010 and finally, Dale and Edward will update you on our ZFP therapeutic programs and our goals for 2010. Following that, we will open up the call for questions. As we begin, I would like to remind everyone that the projections and forward-looking statements that we discussed during this conference call are based upon the information that we currently have available, this information will likely change over time. By discussing our current perception of the market and the future performance of Sangamo with you today, we are not undertaking an obligation to provide updates in the future. Actual results may differ substantially from what we discussed today and no one should assume at a later date that our comments from today are still valid. We alert you to be aware risks and the details in SEC documents as the Company files with the Securities and Exchange Commission specifically our quarterly reports on Form 10-Q exam, and our annual report on Form 10-K. These documents include important factors that could cause the actual results of the Company's operations to differ materially from those contained in our projections or forward-looking statements. Now I'd like to turn the call over to Edward.

Edward Lanphier

President

Thank you, Liz. And thank you all for joining us for our conference call to discuss our first quarter results for 2010. Let me begin by briefly recapping the events of the past few months. We began 2010 by announcing important progress in our clinical programs and the expansion of our clinical pipeline with two new trials, a Phase 2b clinical trial of our lead therapeutic SB-509 in subjects with diabetic neuropathy and a Phase 1 trial of our second Zinc Finger Nuclease product, which is being evaluated in glioblastoma. The first trial is a double blind placebo control repeat dosing Phase 2b trial of SB-509 being carried out in subjects with moderate severity diabetic neuropathy or DN. The design o this study builds on a wealth of data that we have gathered from earlier Phase 1 and Phase 2 trials which have enabled us to identify a patient population with a level of DN severity that we believe will give the greatest response in approvable clinical end points to SB-509 treatment over a 180 daytime period. The study, SB-50-9901 is designed to finalize dose, treatment schedule and primary and secondary approval able end points for pivotal Phase 3 trials. I should also note that the juvenile Diabetes Research Foundation through science advisors know that the SB-509 program and the Phase 1 and Phase 2 data are very well as they were supporters of our 601 trial have also renewed their support for this program and will provide $3 million in funding for the 901 study. As we have said before, we expect to have data from this study in the second half of 2011. The second program is an open label multi-dosing Phase 1 clinical trial designed to evaluate a ZFN therapeutic for the treatment of glioblastoma, type of…

Ward Wolff

Chief Executive Officer

Thank you, Edward, and good afternoon everyone. As you know, after the close of the market today we released our financial results for the first quarter ended March 31, 2010. I'm pleased to review the highlights of those results. Revenues in the first quarter of 2010 were $6.6 million, compared to 3.2 million for the 2009 quarter. The first quarter 2010 revenues were primarily comprised of revenue from Sangamo's collaboration agreements with Sigma Aldrich and Dow AgroSciences and enabling technology agreements as well as 449,000 in revenue from research grants. The increase in revenues was primarily due to the $15 million license payment that we received from Sigma in the fourth quarter of 2009 as part of our expanded agreement, which we are recognizing rapidly into revenue through July 2010. Total operating expenses for the first quarter of 2010 were $10.7 million, compared to $10.2 million for the same period in 2009. Research and development expenses were $7.4 million in the 2010 quarter and $7.3 million for the prior year quarter. General and administrative expenses were $3.3 million in the first quarter of 2010, compared to $2.9 million in the 2009 quarter. The increase in general and administrative expenses was primarily due to increased personnel costs including non-cash employee stock-based compensation and professional fees. For the first quarter of 2010, we reported a consolidated net loss of $4 million or $0.09 cents per share, compared to a net loss of $6.8 million or $0.017 cents per share for the first quarter of 2009. Turning to the balance sheet, we ended the first quarter of 2010 with $77 million in cash, cash equivalent and short-term investments. Our net cash used in operating activities was $8 million for the first quarter. I'm pleased to say that we are on track with respect to our operating plan for 2010 through the first quarter, and we are maintaining our guidance provided at our fourth quarter and end of-year call in February of having cash and investment balances on hand of at least $60 million at the end of 2010. As you will recall, this guidance assumes no new financing or partnering, but it does include anticipated milestones in 2010 from our existing partnership agreements. Thank you and I will now turn the call back over to Edward.

Edward Lanphier

President

Thanks, Ward. With $77 million in cash at the end of the first quarter, we are on track to meet our goal of ending 2010 with at least $60 million in cash and cash equivalents. All while prosecuting clinical trials of three different ZFP Therapeutic products, we are able to achieve this unprecedented level of efficiency by careful management of expenses because of our unique business model, which provides non-dilutive revenues from the non-therapeutic applications of our technology in the form of license fees, research funding and milestone payments as well as significant participation in downstream value through sublicense fees and royalties on product sales. As I mentioned earlier, I have asked Dale to provide you with an outline of the studies and type of data that will be presented in oral presentations at the ADA scientific session this year. The meeting will be held in Orlando, Florida from June 25th through the 29th. As Dale will describe, we will present data from our Phase 2 trial SB-509-701 Bin subjects with severe DN as defined by at least one nerve with an unmeasurable nerve conduction velocity. The presentations will also feature additional data from our SB-509-601 Phase 2 study which addressed SB-509's effect on blood vessel growth using direct histological measurements and on correlations of improvement in nerve health after SB-509 treatment with serum levels of soluble ICAM 1 and V-CAM 1 which are indicators of vascular disease in DN. Dale?

Dale Ando

President

Thank you, Edward. Our lead therapeutic SB-509 is a zinc finger activator of the Vascular Endothelial Growth Factor-actor-A gene or VEGF-A and has been shown to have significant effect on both nerve and blood vessel growth in preclinical and clinical studies. We are evaluating this product clinically in two indications. Diabetic neuropathy, or DN and Amyotrophic Lateral Sclerosis or ALS, and has preclinical programs in other indications such as spinal cord injury, and stroke. We believe that SB-509 dual regenerative effects on both nerves and the blood vessels that supply and nourish those nerves make it a unique disease modifying approach to neurodegenerative condition. Clinical data generated on our SB-509-601 Phase 2 trial demonstrated that SB-509 treatment of subjects with DN resulted in the statistically significant improvement in their Intraepidermal Nerve Fiber Density or IENFD, a direct histological measurement of small sensory nerve fibers in the skin. SB-509 has also shown activity in subjects with severe DN whose nerve damage is sufficiently advanced that nerve conduction velocity, or NCVs cannot be recorded in at least one major nerve by Standard Neurophysiologic Testing. These effects were demonstrated in our Phase 2 trial SB-509-701A, a single blind placebo controlled Phase 2 clinical trial in which 30 subjects were treated intramuscularly in the lower extremity with 60 milligrams of SB-509 and 15 subjects with placebo at the zero and 90. We observed clinically relevant improvements in the mean change in surval NCV at day 180 compared to base line in SB-509, compared to placebo treated subjects. These encouraging results were the basis for an extensive – extension of that protocol SB-509-701B, a single blind placebo controlled Phase 2 clinical trial, in which 30 subjects with severe DN were similarly treated with 60 milligrams of SB-509 and 15 subjects with placebo, but with three…

Edward Lanphier

President

Thank you, Dale. As Dale said, we look forward to updating you on the progress of all of our clinical programs at appropriate medical meetings and on future calls. While our main focus here at Sangamo continues to be the development of ZFP Therapeutics, our partners Sigma Aldrich and Dow AgroSciences are making significant progress in developing and broadening the exposure of our ZFP technology for non-therapeutic applications in life science research applications and in plants. Both groups have made several announcements this quarter that further demonstrate that our ZFP technology is a significant focus in their growth plans over the next several years. In March, Sigma hosted its Annual Business review which served to highlight their new focus on biologic products. Sigma's progress and plans for our ZFN technology featured heavily in this event. The Company is moving the technology along on three fronts, custom ZFNs and kits under their composer trademark, transgenic animals through their SAGE labs and improvements in pharmaceutical production cell lines under the SAFC group. In the last quarter, Sigma announced the addition of the award winning composer product offering with the global release of a targeted integration kit. This kit provides a powerful method for the controlled insertion and expression of any gene in any human cell line. On the transgenic animal front, they are making rapid progress. They recently announced the creation of the world's first p53 knockout rat model an important development that is expected to significantly improve time lines for carcinogenicity screening and reduce time to market for therapeutics. This is in addition to a suite of rat models designed to facilitate more predictive absorption, distribution, metabolism, excretion and toxicity studies, which are to help researchers establish the efficacy of drugs more rapidly and with greater accuracy due to the rat's…

Operator

Operator

Thank you. (Operator Instructions) First question comes from Charles Duncan from JMP securities. Charles Duncan – JMP securities: Hi, guys. Thanks for taking the question and congratulations on a good quarter of progress.

Edward Lanphier

President

Thanks, Charles. Charles Duncan – JMP securities: I had a question on 509. Specifically at ADA you're going to be presenting some data and congratulations on having three abstracts for three presentations. My question is, Edward or perhaps Dale, what would you like to see out of these data not specifically because they haven't been presented. That would enhance your conviction or make you feel good about the investment that you're making in the Phase 2B.

Edward Lanphier

President

Let me start and certainly Dale can add if appropriate. I think, Charles, at this point, we are not going to go a whole lot further than what we outlined in the prepared comments in the script, which were, as you can imagine, a relatively carefully reviewed here. I will say to the question, I think to emphasize a couple of the points in the script, I think the data that will be presented both in the 701A and B trial as well as the additional data of the 601 will continue to emphasize the dual nature of the drug, both the 701A and B trial as well as the neurogenetic component of VEGF-A and the activation of the endogenous gene and I think that continued support around the mechanism of action and the definition of a responder group based upon the – but Dale I'll pause there and see if you want to add anything.

Dale Ando

President

I wouldn't add anything more. I would just say it's important for us to be recognized in this kind of presentation by the experts in diabetic neuropathy for which this session is comprised of.

Edward Lanphier

President

Thanks, Charles. Go ahead. Charles Duncan – JMP securities: So, I guess my question is relative to the patient population in 701, how does that compare to the patient population in your phase 2B?

Edward Lanphier

President

I think that’s not a part of, actually it’s an exclusion criterion in the 901 trial. Dale you want to say more about that? Except the main point is that 701A and B trial again the data will presented be in June but really I think what’s more relevant in terms of the dual mechanism of action on the definition of the responder group around approvable end points is a function of the two presentations that look at the 601 data. Charles Duncan – JMP securities: Okay that makes sense to me and then if I could ask for an update from the ALS trial. Did I miss it or where you guys not prepared to give an update?

Edward Lanphier

President

I think we will update now and we expect to present data complete data set from that trial in the second half of this year as we have previously guided that trial is fully accrued and now we are now in the full-up stages of that and on track to present data from that in the second half of this year. Charles Duncan – JMP securities: And then final question for Ward, your cash guidance, first of all you are doing a great job conserving cash. But your cash guidance for $60 million, if I do the math if you were to straight line the $1 million per quarters suggest that you make it roughly $7 million or so in milestone payments or some other form of payments, is that consistent with what you kind of anticipated this year?

Ward Wolff

Chief Executive Officer

Thanks for questions, Charles, as you know our primary guidance has been around of cash consumed for the year and cash balance at the end of the year. Our operating expense line has been fairly consistent over the last couple of years and if you analyze the Q1 OpEx that would take you into an OpEx range for the year potentially into that $43 million to $47 million kind of a number. But, yes, as you know, we did receive cash from Sigma in last year but if you back into the math it would show that we are cash receipts this year not GAAP revenue would be in the roughly in the $10 million range. Charles Duncan – JMP securities: Okay, that’s what I had. Thanks for the added color guys.

Edward Lanphier

President

Thanks, Charles.

Operator

Operator

Our next question comes from Liana Moussatos from Wedbush. Liana Moussatos – Wedbush: Thank you. This is for Ward. How are we thinking about collaborative revenues for Q2 with respect to your booking on the Sigma payment from Q4, what do we expect Q2 to be a lot higher than Q1?

Ward Wolff

Chief Executive Officer

Liana, as we mentioned at the year-end call, it’s fair to say that we are taking that $15 million in rapidly. So, it’s coming in over the three quarters, so the amount will be recognized in Q2 is about the same as Q1 at least for that piece. Again let me just and I will elaborate a little bit more just to help because I know the models are a little bit difficult when you just have the cash guidance. In terms of top line, a GAAP revenue for the year, we are looking at something that can – the last year maybe a little bit less maybe to keep the $22 million in range in total except the earlier comment to Charles question. Due cash in, up front as we see it is about $10 million, so that we are picking up 2/3rd of that Sigma piece at least for GAAP purposes in Q1 and Q2 totaling about $10 million in total. Liana Moussatos – Wedbush: Thank you very much.

Operator

Operator

Our next question comes from Alastair Mackay from GARP Research. Alastair Mackay – GARP Research: Hi, just following up a little bit on that, Edward I wonder if you could say or talk it in a little more detail how the revenue or cash flows to you from your major partners as they accomplish things like sublicenses or come out with new and diversified products, sell those product. For instance are you receiving quarterly checks or is there a lot of already in compass in the sorts of payments that you got last year from Sigma?

Edward Lanphier

President

No, there is the sort of payments that we got last year from Sigma really part of that new license agreement but on an ongoing basis incremental to the license fee we receive a milestone payments, sublicense fee or royalties on product sales on a quarterly basis. Ward do you want to comment further on that?

Ward Wolff

Chief Executive Officer

No, that’s right. We have a quarterly reconciliation process, Alastair and so we are able to track the broadening customer base and in quite a level of detail but those occurred on a current basis and they aren’t baked into the payments received from Sigma at least both the expansion piece for $15 million last year. Alastair Mackay – GARP Research: And are you receiving as part of that any payments for ZFN or ZFP including biopharmaceutical cell lines or cell lines that were not essentially transferred to Sigma last year?

Edward Lanphier

President

I am not sure I have to question completely right, so we did the license agreement with Sigma in October. They gave them rights to develop and market cell lines for protein production, protein manufacturing. So, they will go out and sell that and we will receive a milestone payments and royalties on those product sales. Alastair Mackay – GARP Research: Got and do you have any update on that or is that pretty much a modest but ongoing business in terms of royalties you are receiving.

Edward Lanphier

President

It’s certainly an ongoing business and what I refer to you as what I discussed in the script and that is Sigma annual business review, were they spent I think a good deal up on talking about the focus and the future of those three business units, including discussion of their goals in terms of growth for the whole biologics area of their business. Alastair Mackay – GARP Research: Okay, great. Thank you.

Operator

Operator

Our next question comes from Ted Tenthoff from Piper Jaffray. Ted Tenthoff – Piper Jaffray: Great. Thank you very much and thanks for taking the question. What I just want to follow up on your comments, did you say revenues for this year would be similar to last year in the $18 million to $22 million that I miss here?

Ward Wolff

Chief Executive Officer

Right. As I said, Ted, in order to give a little more color to the cash guidance which remain essentially the bedrock of our guidance and as you have noticed inside the model and what not, I just want to make sure that people are generally understanding how our model evolves and as Edward pointed out, certain revenues with respect to Sigma and cell line engineering and what not, we certainly have those in our model but its – we will see how that plays out when we get to actual but yes I think its fair to say if you stand back and just look at the various pieces. I think we have laid most of this out but with the cash inflow and the $10 million of amortization largely this new calculation will be recognized this year and the amortization from the prior year. So, yes revenues in the 18 to 22 range would be something that I think can be derived from that cash guidance model. Ted Tenthoff – Piper Jaffray: Got you, that’s super helpful. Now I know from the DAS still, there is M word of about $200,000 or so, is that through out the year or is that kind of all been recognized in the first half of the year, how should we be thinking about that because what I start to do is I kind of back into a collaborative revenue number of a couple 100,000 which in my calculations seems to be down from sort of the annual or even quarterly rate of last year. So, was there any different in the collaborative revenues in 1Q versus 2009 versus last year.

Ward Wolff

Chief Executive Officer

Right, I think what you are saying and correct if I am wrong but DAS amortization was largely winding down at the end of 2009 because we extended the agreement, the piece that was the unamortized piece does recognize throughout 2010. Ted Tenthoff – Piper Jaffray: Okay cool, that’s helpful. And then is there anything different from the collaborative line because I have that coming out at about $600,000 to $700,000 from the first quarter versus what was really $1 million to $2 million to even almost $3 million per quarter last year, are there any major changes there on the collaborative side?

Ward Wolff

Chief Executive Officer

Well again, the milestones are to become somewhat the wild card here, so that we did have significant milestones in Q4 that synched up with our research meeting of these milestones etcetera. Those aren’t ratable across the year they tend to be a function when these milestones were achieved, but yes in Q4 last year in terms of the $10 million plus of revenue, there was a couple of $1 million there in terms of Sigma milestones. Ted Tenthoff – Piper Jaffray: Got you that’s incredibly helpful and just to ask one last thing, if you kind of think about this going forward sort of moving out the amortization rates on revenues and commercial milestones or royalties in commercial milestones from Dow and Sigma. How far out do you think until that would get you to kind of a break even or to offset the therapeutic burn? Do you think about it that way?

Edward Lanphier

President

Ted, as you know we have and we will continue to give annual financials guidance. Looking out to breakeven points and so on, and projecting the revenues associated with that and even projecting what our additional clinical trials might be at that point. I think it's pretty mature. Ted Tenthoff – Piper Jaffray: I understood it, Edward. I appreciate it very much and thanks for the extra color; that’s really helpful.

Ward Wolff

Chief Executive Officer

Okay, Ted.

Operator

Operator

(Operator Instructions) Your next question comes from Joseph Schwartz from Leerink Swann Joseph Schwartz – Leerink Swann: Hi, thanks for taking the question. I was wondering if you could give us an update on your research activities for SB-7 280 since you receive the $14.5 million grant in October last year from the CIRM and how does the treatment strategy for these AIDS lymphoma patients compared to what you are doing in the ongoing Phase I study for this agent?

Edward Lanphier

President

Let me start and then Philip and Dave can jump in, so Joe thanks for the question. There is two programs the SB-7 280 is a program involved in modification of atoll Gus T-cells and as you know that’s ongoing and we guided to having data preliminary data from those studies presented in this calendar year so that’s ongoing. As you pointed out, we also received along with collaborators at City of Hope and USC of $14.5 million grant from the California Institute for Regenerative Medicine to apply this Zinc Finger Nuclease that disrupt the CCR5 gene and hematopoietic stem cell. And so that grant is moving forward and getting collaboration with those groups and I guess let me stop and pause and see if that covers your questions or if you want more color around anyone of those programs. Joseph Schwartz – Leerink Swann: Yes, I guess is there an clinical trial enrolling subjects here in and is it – what cells are they targeted against anything that –

Edward Lanphier

President

Why don’t I let Philip give you a little more color on that?

Philip Gregory

Analyst

In the term funded work, we are working some hematopoietic stem cells, so CD positive stem cells that have the capacity to regenerate the entire hematopoietic system. So, unlike the T-cells which essentially remain T-cells these are true stem cells that have the regenerative capability and so the studies are aimed at putting our CCR5 ZFN reagents into the stem cell class for patients who would normally will be receiving a bone marrow transplant for aids-related lymphoma patients.

Dale Ando

President

Quite analogous Joe to the patient who is treated in Berlin a couple of years ago. They both had lymphoma as well as HIV and received transplant CD34 positive cells from a donor that was naturally – had the natural Delta 32 Mutation. So, quite an analogous to that clinical setting that clinical experience.

Philip Gregory

Analyst

But, in terms of that, we are at the research level for this program and the grant is to fund activities that take us from early pre-clinical efficacy data which we already have through the sort of iron DN enabling studies that will allow us to go to clinical, so that’s the stage of research that this particular program is at the moment. Joseph Schwartz – Leerink Swann: It's certainly intriguing; do you have timeframe over which you expect to be able to foresee an IND submission?

Edward Lanphier

President

Joe, this is Edward. So, this is the I guess what you would call from an external point of view the non-flexi part of the program, this is the process development work, this is the development of release criteria and assays and optimizing the expansion of these cells and modification and so and so forth. So, there is a lot of blocking and tackling to go on here, number one. Number two, this is the first time a Zinc Finger Nuclease stem cell therapy has been moved forward into formal pre-clinical development. So, we hope to and we will be moving it forward as quickly as we can but I think to put a specific timeline on an IND expectation is a little bit premature. Joseph Schwartz – Leerink Swann: And the way in which you get it into the cells, does it differ with 7 to 8 T, I recall that took a while to get into the clinic and there might have been a change with the vector that was used or your strategy somehow. Can you help us understand what hurdle needs to be overcome technological for this aspect of the program.

Edward Lanphier

President

So, the work envisioned was exactly the same vectorology that was used in the T-cell manufacturing process. So, we’re that particular aspect should not confound the rate at which we didn’t get this IND. Joseph Schwartz – Leerink Swann: Great, thanks.

Edward Lanphier

President

Thanks, Joe.

Operator

Operator

Edward Lanphier

President

Operator

Operator

Ladies and gentlemen, thank you for participating in today’s conference. This concludes our program for today. You may all disconnect and have a wonderful day.